Laparoscopic sizing instrument

ABSTRACT

An apparatus includes a handle assembly, a shaft assembly, an end effector, and an auto-tensioning feature. The handle assembly includes a body and a plunger. The shaft assembly includes an external sheath that is fixed to the handle body and an interior shaft that is coupled to the plunger. The interior shaft is slidable relative to the external sheath. The end effector is configured to encompass a bodily lumen and includes a flexible member extending distally from the interior shaft. A first coupling element is fixed to the distal tip of the flexible member. A second coupling element is fixed to the external sheath. The first and second coupling elements are magnetically attracted to each other and are biased toward each other such that the flexible member defines an adjustable loop. The auto-tensioning feature is configured to bias the plunger portion proximally relative to the handle body.

FIELD OF THE INVENTION

The invention pertains to laparoscopic sizing instruments. Morespecifically, the invention pertains to laparoscopic sizing instrumentsfor a biological lumen and/or passageway.

BACKGROUND

In some instances, it may be desirable to place a medical implant withinor surrounding a biological lumen/passageway in order to improve orassist the function of, or otherwise affect, the biologicallumen/passageway. Examples of such biological lumens/passagewaysinclude, but are not limited to, the esophagus, a fallopian tube, aurethra, or a blood vessel. Some biological passages normally functionby expanding and contracting actively or passively to regulate the flowof solids, liquids, gasses, or a combination thereof. The ability of abiological passage to expand and contract may be compromised by defectsor disease. One merely illustrative example of a condition associatedwith decreased functionality of a body passage is Gastro EsophagealReflux Disease (or “GERD”), which effects the esophagus.

A normal, heathy, esophagus is a muscular tube that carries food fromthe mouth, through the chest cavity and into the upper part of thestomach. A small-valved opening in the esophagus, called the loweresophageal sphincter (or “LES”), regulates the passage of food from theesophagus into the stomach, as well as the passage of acidic fluids andfood from the stomach toward the esophagus. The LES may also regulatestomach intra-gastric pressures. A healthy LES may contain pressure ofgasses within the stomach at around 10 mm Hg greater than normalintragastrical pressure, thereby impeding acidic gases/fluids fromrefluxing from the stomach back into the esophagus. When functioningproperly, a pressure difference greater than 10 mm Hg may regulate whenthe LES opens to allow gasses to be vented from the stomach toward theesophagus.

If the LES relaxes, atrophies, or degrades for any reason, the LES maycease functioning properly. Therefore, the LES may fail to sufficientlycontain pressure of gasses within the stomach such that acidic contentsof the stomach may travel back into the esophagus, resulting in refluxsymptoms. Two primary components that control the LES are the intrinsicsmooth muscle of the distal esophagus wall and the skeletal muscle ofthe crural diaphragm or esophageal hiatus. A causation of esophagealreflux, which may be associated with GERD, is relaxation of one or bothof the smooth muscle of the distal esophagus wall or the hiataldiaphragm sphincter mechanisms. Chronic or excessive acid refluxexposure may cause esophageal damage. Conventionally, treatment for GERDmay involve either open or endoscopic surgical procedures. Someprocedures may include a fundoplication that mobilizes of the stomachrelative to the lower esophagus, or suturing a pleat of tissue betweenthe LES and the stomach to make the lower esophagus tighter.

Examples of devices and methods that have been developed to treatanatomical lumens by providing sphincter augmentation are described inU.S. Pat. No. 7,175,589, entitled “Methods and Devices for Luminal andSphincter Augmentation,” issued Feb. 13, 2007, the disclosure of whichis incorporated by reference herein; U.S. Pat. No. 7,695,427, entitled“Methods and Apparatus for Treating Body Tissue Sphincters and theLike,” issued Apr. 13, 2010, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 8,070,670, entitled “Methods and Devicesfor Luminal and Sphincter Augmentation,” issued Dec. 6, 2011, thedisclosure of which is incorporated by reference herein; and U.S. Pat.No. 8,734,475, entitled “Medical Implant with Floating Magnets,” issuedMay 27, 2014, the disclosure of which is incorporated by referenceherein.

While various kinds and types of instruments have been made and used totreat or otherwise engage anatomical lumens, it is believed that no oneprior to the inventors has made or used an invention as describedherein.

SUMMARY OF THE INVENTION

An apparatus is used to encompass a bodily lumen. The apparatus includesa handle assembly, a shaft assembly, and end effector, and anauto-tensioning feature. The handle assembly includes a handle body anda plunger portion slidably coupled with the handle body. The shaftassembly extends distally from the handle assembly. The shaft assemblyincludes an external sheath fixed to the handle body, and an interiorshaft coupled to the plunger portion. The interior shaft is slidablerelative to the external sheath. The end effector is configured toencompass the bodily lumen. The end effector includes a flexible member,a first coupling element, and a second coupling element. The flexiblemember includes a distal tip and extends distally form the interiorshaft. The first coupling element is fixed to the distal tip of theflexible member. The second coupling element is fixed to the externalsheath. The first and second coupling elements are biased toward eachother such that the flexible member defines an adjustable loop. Theauto-tensioning feature is configured to bias the plunger portionproximally relative to the handle body.

An apparatus is used to encompass a bodily lumen. The apparatus includesa handle assembly, a shaft assembly, and end effector, and anauto-tensioning feature. The handle assembly includes a handle body anda plunger portion slidably coupled with the handle body. The shaftassembly extends distally from the handle assembly. The shaft assemblyincludes an external sheath fixed to the handle body, and an interiorshaft coupled to the plunger portion. The interior shaft is slidablerelative to the external sheath. The end effector is configured toencompass the bodily lumen. The end effector includes a flexible member,which includes a distal tip. The flexible member extends distally fromthe interior shaft. The flexible member is biased to define anadjustable loop. The auto-tensioning feature is position within theexternal sheath and around the interior shaft. The auto-tensioningfeature is configured to bias the plunger portion proximally relative tothe handle body to reduce the adjustable loop defined by the flexiblemember.

An apparatus is used to encompass a bodily lumen. The apparatus includesa handle assembly, a shaft assembly, and end effector, and anauto-tensioning feature. The handle assembly includes a static body andan actuating slidably coupled with the static body. The shaft assemblyextends distally from the handle assembly. The shaft assembly includesan external sheath fixed to the static body, and an interior shaftcoupled to the actuating body. The external sheath defines a distalopening. The end effector is configured to encompass the bodily lumen.The end effector includes a flexible member attached to the interiorshaft. A distal portion of the flexible member extends distally past thedistal opening of the external sheath. The distal portion of theflexible member is biased to form an adjustable loop. Theauto-tensioning feature is configured to bias the actuating body portionproximally relative to the static body.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim this technology, it is believed this technologywill be better understood from the following description of certainexamples taken in conjunction with the accompanying drawings, in whichlike reference numerals identify the same elements and in which:

FIG. 1 depicts a cross-sectional side view, taken along a coronal planeof the body, of a biological passage;

FIG. 2 depicts a cross-sectional isometric view, taken along a coronalplane of the body, of a human esophago-gastric junction;

FIG. 3 depicts a perspective view of an exemplary laparoscopic sizinginstrument that may be used to measure the biological passage of FIG. 1;

FIG. 4 depicts an exploded perspective view of the laparoscopic sizinginstrument of FIG. 3 ;

FIG. 5 depicts a cross-sectional perspective view of a handle assemblyof the laparoscopic sizing instrument of FIG. 3 , taken along line 5-5of FIG. 3 ;

FIG. 6 depicts an enlarged cross-sectional perspective view of thehandle assembly shown in FIG. 5 , taken along line 5-5 of FIG. 3 ;

FIG. 7 depicts a cross-sectional perspective view of a shaft assemblyand end effector of the laparoscopic sizing instrument of FIG. 3 , takenalong line 5-5 of FIG. 3 ;

FIG. 8 depicts a perspective view of a grip portion of the handleassembly of FIG. 5 ;

FIG. 9 depicts a cross sectional perspective view of the grip portion ofFIG. 8 , taken along line 9-9 of FIG. 8 ;

FIG. 10 depicts a perspective view of a distal end of an exterior sheathof the shaft assembly of FIG. 7 ;

FIG. 11 depicts a cross-sectional perspective view of the distal end ofthe exterior sheath of FIG. 10 , taken along line 11-11 of FIG. 10 ;

FIG. 12 depicts a perspective view of a plunger portion of the handleassembly of FIG. 5 ;

FIG. 13 depicts a cross-sectional perspective view of the plungerportion of FIG. 12 , taken along line 13-13 of FIG. 12 ;

FIG. 14 depicts an enlarged cross-sectional perspective view of theplunger portion shown in FIG. 13 , taken along line 13-13 of FIG. 12 ;

FIG. 15 depicts a perspective view of the translating interior shaft ofthe shaft assembly of FIG. 7 ;

FIG. 16 depicts a cross-sectional perspective view of the translatinginterior shaft of FIG. 15 , taken along line 16-16 of FIG. 15 ;

FIG. 17 depicts a perspective view of a locking clip of the laparoscopicsizing instrument of FIG. 3 ;

FIG. 18A depicts a top plan view of the end effector and shaft assemblyof FIG. 7 placed adjacent to a lower esophageal sphincter, where the endeffector is in a distal, closed, position;

FIG. 18B depicts a top plan view of the end effector and shaft assemblyof FIG. 7 placed adjacent to the lower esophageal sphincter, where theend effector is in a distal, opened, position;

FIG. 18C depicts a top plan view of the end effector and shaft assemblyof FIG. 7 , where the end effector is in the distal, closed, positionwhile the end effector surrounds the lower esophageal sphincter;

FIG. 18D depicts a top plan view of the end effector and shaft assemblyof FIG. 7 , where the end effector is in a retracted, closed, positionwhile the end effector surrounds the lower esophageal sphincter;

FIG. 19A depicts a top plan view of the handle assembly of FIG. 5 ,where the plunger portion of FIG. 12 is in a distal positioncorresponding with the end effector in the distal, closed, position;

FIG. 19B depicts a top plan view of the handle assembly of FIG. 5 ,where the plunger portion of FIG. 12 is in a proximal positioncorresponding with the end effector in the retracted, closed, position;

FIG. 20A depicts a cross-sectional perspective view of the handleassembly of FIG. 5 , where the plunger portion of FIG. 12 is in a distalposition corresponding with the end effector in the distal, closed,position; and

FIG. 20B depicts a cross-sectional perspective view of the handleassembly of FIG. 5 , where the plunger portion of FIG. 12 is in aproximal position corresponding with the end effector in the retracted,closed, position.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the technology may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presenttechnology, and together with the description serve to explain theprinciples of the technology; it being understood, however, that thistechnology is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

I. Overview

FIGS. 1-2 show selected portions of human anatomy, which includes anesophagus (2) extending from the mouth, through a hiatus (8) defined bya diaphragm (10), and into a stomach (4). Esophagus (2) also includes adistal esophagus (3) and an LES (6). LES (6) is located along distalesophagus (3) adjacent to the junction of esophagus (2) and stomach (4).The portion of LES (6) extending through hiatus (8) is supported bydiaphragm (10). When functioning properly, LES (6) is configured totransition between an occluded state and an opened state (as shown inFIG. 2 ). As best seen in FIG. 2 , LES (6) includes a plurality of slingfibers (12). Sling fibers (12) are smooth muscle tissue that may helpregulate LES (6) transition between the occluded state and the openstate. Hiatus (8) of diaphragm (10) may also help LES (6) transitionbetween the occluded state and the open state.

A healthy LES (6) transitions between the occluded state and the openedstate in order to act as a valve. In other words, a healthy LES (6) maytransition from the occluded state to the opened state in order to allowsolids, liquids, and/or gasses to selectively travel between esophagus(2) and stomach (4). For example, a healthy LES (6) may transition fromthe occluded state to the opened state to permit a bolus of food totravel from esophagus (2) into stomach (4) during peristalsis; or tovent intra-gastric pressure from stomach (4) toward esophagus (2).Additionally, in the occluded state, a healthy LES (6) may preventdigesting food and acidic fluid from exiting stomach (4) back intoesophagus (2).

If LES (6) ceases functioning properly by prematurely relaxing, andthereby improperly transitioning esophagus (2) from the occluded stateto the opened state, undesirable consequences may occur. Examples ofsuch undesirable consequences may include acidic reflux from stomach (4)into esophagus (2), esophageal damage, inflamed or ulcerated mucosa,hiatal hernias, other GERD symptoms, or other undesirable consequencesas will be apparent to one having ordinary skill in the art in view ofthe teachings herein. Therefore, if an individual has an LES (6) thatprematurely relaxes, causing improper transitions from the occludedstate to the opened state, it may be desirable to insert an implantaround a malfunctioning LES (6) such that the implant and/or LES (6) mayproperly transition between the occluded state and the opened state.

Such an implant may include a circumferential array of magnetic elementsthat are magnetically attracted toward adjacent magnetic elements. Suchmagnetic elements may expand and contract relative to each other whileencompassing the exterior of a malfunctioning LES (6). Therefore, themagnetic attraction between adjacent magnetic elements may help amalfunction LES (6) properly remain in an occluded state; while theability for magnetic elements to expand and contract relative to eachother may allow an LES (6) to suitably transition into the opened state.While magnetic elements are used to bias a malfunctioning LES (6) towardan occluded state while also allowing a malfunctioning LES (6) tosuitably transition into an open state, any other type of biasingelements may be used as would be apparent to one having ordinary skillin the art in view of the teachings herein. Merely illustrative examplesof implants that may be used to encompass the exterior of amalfunctioning LES (6) are disclosed in U.S. Pat. No. 7,695,427, thedisclosure of which is incorporated by reference herein and U.S. patentapplication Ser. No. 15/664,665, entitled “Method for Assisting aSphincter,” filed Jul. 31, 2017, the disclosure of which is incorporatedby reference herein.

II. Exemplary Laparoscopic Sizing Instrument

As mentioned above, certain implants may encompass a malfunctioning LES(6) within the body to suitably assist such sphincters in properlytransitioning between the occluded state and the open state. Since thediameter of the LES (6) may vary from patient to patient, it may benecessary or otherwise desirable to vary the length of an implant, tocorrespond with the diameter of the LES (6) of the patient at hand, tothereby maximize the likelihood of a successful outcome. The suitablelength of an implant (i.e. circumference of an implant when attached tothe outer diameter of LES (6)) may be determined by measuring the outerdiameter of the LES (6) of the patient at hand. For instance, if animplant includes an array of magnetic elements, the number of magneticelements used for a specific implant may be determined by the outerdiameter of LES (6). The larger the outer diameter, the more magneticelements will be used; and the smaller the outer diameter, the lessmagnetic elements will be used.

Since the outer diameter of LES (6) may vary depending on the patient,and this may influence the configuration of an implant that is to beplaced around the LES (6), it may be desirable to use a sizinginstrument having an end effector that is configured to encompass andmeasure an outer diameter of an LES (6) of an individual patient. Anoperator may utilize the measurement of LES (6) to determine what sizeimplant should be used for an individual patient. Upon identifying theappropriate size of the implant, the operator may select theappropriately sized implant from a plurality of available implants.Alternatively, the operator may modify the length of an implant toachieve the appropriate size.

Additionally, in some instances, it may be desirable to provide a sizinginstrument with an auto-tensioning feature that is configured to drivethe end effector of a sizing instrument into proper engagement with theouter diameter of LES (6). An auto-tensioning feature may prevent anoperator from manually driving an end effector too far into engagementwith the outer diameter of LES (6) such that end effector no longersuitably encompasses LES (6) for an accurate measurement of LES (6), orsuch that the hollow organ deforms. An auto-tensioning feature may alsoprevent an operator from manually driving an end effector too loose suchthat the end effector does not properly engage the outer diameter of LES(6). If an operator manually drives an end effector too far or too looseinto engagement with the outer diameter of LES (6), this may ultimatelyprovide an inaccurate measurement of the outer diameter of LES (6),which may lead to using an implant having an improper length. Using animplant having improper length (i.e., too long) may prevent implant ofassisting LES (6) in appropriately closing. Additionally, using animplant having improper length (i.e., too short) may lead to potentialdysphagia or erosion into tissue where the implant may be too tight.

The following describes an exemplary laparoscopic sizing instrument(100) having an auto-tensioning feature (166) that may be utilized toprovide a proper engagement between an end effector (170) of sizinginstrument (100) and the outer diameter of LES (6). While sizinginstrument (100) is described herein in the context of measuring the LES(6) of esophagus (2), variations of sizing instrument (100) may be usedto measure the outer circumference of any other anatomical passageway,including but not limited to the pylorus, the intestinal regionsurrounding the ileocecal sphincter, a passageway associated with thesphincter of Oddi, a region of a urethra surrounding the urethralsphincter, a region of the rectum, a region surrounding the upperesophageal sphincter, or any other anatomical passageway.

As shown in FIGS. 3-4 , sizing instrument (100) of the present exampleincludes a handle assembly (102), a shaft assembly (160) extendingdistally from handle assembly (102), and an end effector (170) extendingdistally from handle assembly (102). Handle assembly (102) includes agrip portion (110), a plunger portion (130), and a locking clip (150).Shaft assembly (160) includes an exterior sheath (162), a translatinginterior shaft (164) slidably housed within exterior sheath (162), andauto-tensioning feature (166) housed within exterior sheath (162) andaround a portion of interior shaft (164). End effector (170) includes aresilient flexible tube (172) extending distally from translatinginterior shaft (164), a first magnet (174) attached to a distal tip(178) of resilient flexible tube (172), and a second magnet (176)located at an open distal end (165) of exterior sheath (162). Whilesecond magnet (176) is not shown in FIGS. 3-4 , second magnet (176) isshown in FIGS. 7, 11, and 18A-18D. In some variations, distal end (165)of exterior sheath (162) simply includes a ferrous cuff or other ferrouselement that is configured to magnetically couple with first magnet(174); instead of including second magnet (176). Resilient flexible tube(172) defines an adjustable loop, and is resiliently biased to assumethe loop configuration shown in FIGS. 3-4 . While the current exampleincludes resilient flexible tube (172), any other type of elongatedresilient flexible member may be used as would be apparent to one havingordinary skill in the art in view of the teachings herein.

As will be described in greater detail below, resilient flexible tube(172) is configured to transition between a closed position (as shown inFIGS. 18A and 18C) and an opened position (as shown in FIG. 18B) inorder to selectively encompass LES (6). As will also be described ingreater detail below, auto-tensioning feature (166) is configured todecrease the diameter of the adjustable loop defined by resilientflexible tube (172) until resilient flexible tube (172) sufficientlyengages the outer diameter of LES (6) (as shown in FIG. 18D).

As best seen in FIGS. 8-9 , grip portion (110) of handle assembly (102)includes an elongated body (112) extending from a proximal sleeve (114)toward a distal locking collar (116). Grip portion (110) also includes apair of finger grips (118) extending laterally from proximal sleeve(114). Finger grips (118) may allow an operator to better grasp gripportion (110) during exemplary use. Elongated body (112) includes aplurality of indicator markings (115). Indicator markings (115) aredimensioned to correspond with an indicator (146) on plunger portion(130) when end effector (170) sufficiently engages the outer diameter ofLES (6), thereby indicating the suitable size of implant to be used inconjunction with LES (6). In the present example, indicator markings(115) have a series of sections ranging between 13 and 17, where eachnumber corresponds with a specific sized implant. For example, ifindicator (146) on plunger portion (130) is aligned within the rangeassociated with “15” when end effector (170) sufficiently engages theouter diameter of LES (6), a corresponding size “15” implant may be usedin conjunction with the recently measured LES (6). While indicatormarkings (115) in the current example ranges between 13 and 17, anysuitable range may be used as would be apparent to one having ordinaryskill in the art in view of the teachings herein. Additionally, anysuitable unit may be used as would be apparent having ordinary skill inthe art in view of the teachings herein. For example, millimeters may bethe identified unit.

Proximal sleeve (114) defines a sleeve channel (120), elongated body(112) defines a plunger window (122), and distal locking collar (116)defines a collar channel (124). Collar channel (124), plunger window(122), and sleeve channel (120) are dimensioned to receive exteriorsheath (162); while distal locking collar (116) couples with exteriorsheath (162) of shaft assembly (160) such that exterior sheath (162) andgrip portion (110) are fixed relative to each other. Plunger window(122) and sleeve channel (120) are dimensioned to slidably receiveplunger portion (130) such that plunger portion (130) may translaterelative to grip portion (110). Additionally, as will be described ingreater detail below, the proximal portion of exterior sheath (162) ishoused within plunger window (122) and sleeve channel (120) such thatexterior sheath (162) may slidably support plunger portion (130) duringexemplary use. As best seen in FIG. 9 , an open proximal end (163) ofexterior sheath (162) is housed within sleeve channel (120) of proximalsleeve (114). However, this is merely optional, as open proximal end(163) may be located at any other suitable position as would be apparentto one having ordinary skill in the art in view of the teachings herein.

As best seen in FIG. 7 and FIGS. 10-11 , the distal portion of exteriorsheath (162) houses a spacer tube (168) and second magnet (176). Spacertube (168) and second magnet (176) are both fixed within in the interiorof sheath (162). As best shown in FIG. 7 , spacer tube (168) isconfigured to abut against a distal end of auto-tensioning feature(166), thereby acting as a mechanical ground for auto-tensioning feature(166).

FIGS. 12-14 show plunger portion (130) of handle assembly (102). Plungerportion (130) extends from a proximal portion (132) to a distal portion(134). As mentioned above, plunger portion (130) is slidably housedwithin sleeve channel (120) and plunger window (122) of grip portion(110). Plunger portion (130) includes external plunger body (136)defining a cavity (140) extending into a distal opening (142); and asupport collar (138) housed within cavity (140). External plunger body(136) includes indicator (146) and a pair of flats (131). As best seenin FIGS. 20A-20B, flats (131) are dimensioned to abut against flats(121) of proximal sleeve (114) such that external plunger body (136) maynot rotate relative to grip portion (110). Therefore, plunger portion(130) may translate relative to grip portion (110), but plunger portion(130) may not rotate about its own longitudinal axis relative to gripportion (110).

External plunger body (136) also defines a pair of locking recesses(135). As will be described in greater detail below, locking recesses(135) are configured to engage a locking clip (150) while plungerportion (130) is in a distal position such that plunger portion (130) islongitudinally fixed relative to grip portion (110) while simultaneouslycompressing auto-tensioning feature (166). As will be described ingreater detail below, locking clip (150) may be removed from plungerportion (130) such that auto-tensioning feature (166) may proximallydrive plunger portion (130) relative to grip portion (110).

As best seen in FIGS. 5-6 and FIG. 13 , support collar (138) is fixed toa proximal end of translating interior shaft (164). Additionally,support collar (138) is fixed to external plunger body (136). Therefore,interior shaft (164) may actuate with plunger portion (130) relative togrip portion (110) and exterior sheath (162). As best seen in FIG. 5 andFIGS. 20A-20B, an external surface of support collar (138) and aninterior surface of external plunger body (136) define a slide gap(144). As mentioned above, exterior sheath (162) may slidably supportplunger portion (130) during exemplary use. In the present example,slide gap (144) is dimensioned to slidably receive the proximal portionof exterior sheath (162) located within plunger window (122) and sleevechannel (120) such that exterior sheath (162) may slidably supportplunger portion (130). In other words, proximal opening (142) and cavity(140) of external plunger body (136) slidably receives exterior sheath(162), while a portion of support collar (138) is slidably housed withinexterior sheath (162).

As mentioned above, and as best seen in FIG. 7 , end effector (170)includes resilient flexible tube (172), first magnet (174) associatedwith distal tip (178) of resilient flexible tube (172), and secondmagnet (176) associated with open distal end (165) of exterior sheath(162). Resilient flexible tube (172) is biased toward a closed position(as shown in FIG. 7 ). Resilient flexible tube (172) is configured toflex from the closed position (as shown in FIG. 18A) to an openedposition (as shown in FIG. 18B) in response to an external force.Resilient flexible tube (172) is also resiliently biased to flex backfrom the opened position to the closed position (as shown in FIG. 18C)after an external force is no longer acting on resilient flexible tube(172). In other words, flexible tube (172) may flex such that distal tip(178) of tube (172) does not make contact with open distal end (165) ofexterior sheath (162), thereby “opening” the tube (172). Resilientflexible tube (172) may include a leaf spring to bias itself toward theclosed position. Alternatively, resilient flexible tube (172) may bebiased to the position shown in FIG. 7 by any suitable means as would beapparent to one having ordinary skill in the art in view of theteachings herein. For instance, resilient flexible tube (172) may beconstructed of a shape memory material.

As also mentioned above, resilient flexible tube (172) is coupled to adistal end of translating interior shaft (164), which is coupled toplunger portion (130). Therefore, resilient flexible tube (172) mayactuate relative to exterior sheath (162) in response to movement ofplunger portion (130). As shown between FIGS. 18C-18D, movement ofresilient flexible tube (172) relative to exterior sheath (162) affectsthe dimension of the loop defined by resilient flexible tube (172). Inparticular, the loop defined by tube (172) may become larger in responseto distal translation of plunger portion (130); while the loop definedby tube (172) may become smaller in response to proximal translation ofplunger portion (130). Therefore, the loop defined resilient flexibletube (172) is largest when plunger portion (130) is in the most distalposition. The size of the loop defined by resilient flexible tube (172)may be determined from the longitudinal position of indicator (146) onplunger portion (130) relative to indicator markings (115) on gripportion (110).

First and second magnets (174, 176) are attracted to each other suchthat distal tip (178) of resilient flexible tube (172) is biased towardengagement with open distal end (165) of exterior sheath (162). As notedabove, second magnet (176) may be replaced with a ferrous element (e.g.,metallic cuff, etc.) in some variations. In the present example, firstand second magnets (175, 176) may help ensure that distal tip (178) ofresilient flexible tube (172) maintains contact with open distal end(165) of exterior sheath (162) even after the loop defined by resilientflexible tube (172) decreases in diameter. In other words, first andsecond magnets (174, 176) may help ensure resilient flexible tube (172)remains in a closed position as the loop defined by resilient flexibletube (172) decreases in diameter due to translation of plunger portion(130). In other words, first and second magnets (174, 176) may helpensure resilient flexible tube (172) remains fully encompassed aroundLES (6) such that resilient flexible tube (172) may suitable engage theouter diameter of LES (6) during exemplary use.

Additionally, a distal end of support collar (138) abuts against aproximal end of auto-tensioning feature (166). As mentioned above,auto-tensioning feature (166) also abuts against spacer tube (168) ofexterior sheath (162), such that spacer tube (168) acts as a mechanicalground for auto-tensioning feature (166). Therefore, auto-tensioningfeature (166) may compress and expand based on the distance defined byspacer tube (168) of exterior sheath (162) and support collar (138) ofplunger portion (130). In particular, auto-tensioning feature (166) isconfigured to bias plunger portion (130) proximally relative to gripportion (110) of handle assembly (102). Because plunger portion (130) isslidably coupled to grip portion (110) and exterior sheath (162), thebiasing force provided by auto-tensioning feature (166) may actuateplunger portion (130) and translating interior shaft (164) in theproximal direction relative to both grip portion (110) and exteriorsheath (162).

An operator may actuate plunger portion (130) distally relative to gripportion (110) toward the distal position (as shown in FIGS. 5-6, 19A,and 20A), which in turn compresses auto-tensioning feature (166) betweenspacer tube (168) and support collar (138). The operator may holdplunger portion (130) in the distal position by overcoming the biasingforce of auto-tensioning feature (166) manually or by utilizing lockingclip (150).

Locking clip (150) includes a first leg (152) and a second leg (154)that are configured to flex toward and away from each other. Each leg(152, 154) includes a respective locking protrusion (156, 158). As bestseen in FIG. 6 , legs (152, 154) are dimensioned to rest against aplunger portion (130) such that locking protrusions (156, 158) arehoused within locking recesses (135) while plunger portion (130) is inthe distal position. Additionally, a proximally facing surface oflocking clip (150) simultaneously abuts against a distal face ofproximal sleeve (114). Therefore, locking clip (150) may selectivelykeep plunger portion (130) in the distal position when lockingprotrusions (156, 158) are received within locking recesses (135). Whendesired, the operator may manually release plunger portion (130) orremove locking clip (150) such that auto-tensioning feature (166) drivesplunger portion (130) and translating interior shaft (164) proximally.In other words, auto-tensioning feature (166) may drive plunger portion(130), interior shaft (164), and resilient flexible tube (172) in orderto selectively decrease the dimensions of the loop defined by resilientflexible tube (172).

In the current example, auto-tensioning feature (166) includes acompressed coil spring associated with shaft assembly (160) and is usedto bias plunger portion (130) in the proximal direction relative to gripportion (110). However, auto-tensioning feature (166) may be associatedwith other portions of instrument (100), such as handle assembly (102);and may include any other suitable kind of biasing structure that may beused to proximally bias plunger portion (130) as would be apparent toone having ordinary skill in the art in view of the teachings herein.

For instance, as one merely illustrative variation, a torsional springand rotating gear may be rotatably coupled to grip portion (110), whilea rack may be attached to plunger portion (130) such that the rackmeshes with the rotating gear. Such a torsional spring may bias therotating gear to a first angular position associated with plungerportion (130) being in a completely proximal position. The operator maypush plunger portion (130) distally such that the rack of plungerportion (130) rotates the gear and the torsional spring to a secondangular position associated with plunger portion (130) in a completelydistal position. The operator may release plunger portion (130) suchthat the torsional spring drives the rotating gear, which in turn drivesthe rack and plunger portion (130) such that end effector (170) properlyengages LES (6) in accordance with the description herein. Attentively,a torsional spring may be incorporated with any other suitablemechanisms utilized to convert angular motion into linear motion thatwould be apparent to one having ordinary skill in the art in view of theteachings herein, such as a threaded relationship, a cammingrelationship, etc. As yet another merely illustrative variation, one ormore leaf springs or compressible fluid bladders may be used toresiliently bias plunger portion (130) proximally relative to exteriorsheath (162). Still other variations will be apparent to those ofordinary skill in the art in view of the teachings herein.

FIGS. 18A-20B show an exemplary use of laparoscopic sizing instrument(100). First, as shown in FIG. 18A, an operator may insert end effector(170) and a distal portion of shaft assembly (160) into a patientlaparoscopically such that resilient flexible tube (172) is adjacent toLES (6). FIGS. 19A and 20A show handle assembly (102) corresponding withend effector (170) shown in FIG. 18A. During initial insertion of endeffector (170) into the patient, flexible tube (172) may be deformed toa straight configuration in order to enable flexible tube (172) tofreely pass through a cannula of a trocar or some other passagewaythrough the patient. By way of example only, plunger portion (130) andinterior shaft (164) may be in a proximal-most position, with flexibletube (172) contained within exterior sheath (162), and with a proximaledge of distal tip (178) abutting a distal edge of distal end (165),while end effector (170) is being inserted into the patient. As anothermerely illustrative example, the operator may grasp flexible tube (172)and substantially straighten flexible tube (172) to assist in feedingflexible tube (172) through a passageway, without necessarily retractingplunger portion (130) and interior shaft (164) to a proximal-mostposition while inserting end effector (170) into the patient.

As shown in FIG. 18A, after end effector (170) has been inserted intothe patient, end effector (170) is positioned near the LES (6). Asshown, resilient flexible tube (172) is in a closed positioncorresponding with plunger portion (130) located at the distal positionat this stage. Therefore, as mentioned above, with plunger portion (130)at the distal position, resilient flexible tube (172) forms the largestloop. As best shown in FIGS. 19A and 20A, the proximal bias force ofauto-tensioning feature (166) is overcome by utilizing locking clip(150) in accordance with the description above. Of course, the operatormay also manually hold plunger portion (130) in the distal position toovercome the proximal bias force of auto-tensioning feature (166). Tothe extent that plunger portion (130) and interior shaft (164) weremoved to a proximal-most position while inserting end effector (170)into the patient, plunger portion (130) may be advanced distallyrelative to grip portion (110) in order to achieve the configurationshown in FIG. 18A.

Next, as shown in FIG. 18B, the operator may grasp and pull a portion ofresilient flexible tube (172) in order to overcome the biasing force ofboth tube (172) and magnets (174, 176) to transition resilient flexibletube (172) from the closed position to the opened position. In thepresent example, the operator may use a conventional grasping instrument(50) to pull tube (172) into the opened position. Alternatively, anyother suitable instrument may be used as would be apparent to one havingordinary skill in the art in view of the teachings herein. Withresilient flexible tube (172) in the opened position, the operator mayadjust the position of end effector (170) such that LES (6) is next toopen distal end (165) of exterior sheath (162). At this stage, handleassembly (102) is still in the position shown in FIGS. 19A and 20A.

Next, as shown in FIG. 18C, the operator may release resilient flexibletube (172) from grasping instrument (50), such that tube (172)resiliently returns to the closed position. At this point, LES (6) isencompassed by resilient flexible tube (172). At this stage, handleassembly (102) is still in the position shown in FIGS. 19A and 20A.Therefore, plunger portion (130) is still in the distal position suchthat the loop defined by tube (172) is still at its largest dimension.At this point, tube (172) is not suitably engaged with LES (6) tomeasure the outer diameter of LES (6).

With resilient flexible tube (172) properly encompassing LES (6) in theclosed position, the operator may pull locking clip (150) away from therest of handle assembly (102). With locking clip (150) no longer engagedbetween plunger portion (130) and grip portion (110), the proximal biasforce of auto-tensioning feature (166) drives plunger portion (130)proximally, thereby translating interior haft (164) and resilientflexible tube (172) proximally until tube (172) suitably engages theouter diameter of LES (6). With resilient flexible tube (172) suitablyengaging LES (6), plunger portion (130) will remain stationary relativeto grip portion (110). At this point in time, the operator may visuallyconfirm the location of indicator (146) relative to indicator markings(115) in order to determine the proper size for an exemplary implant. Inthe current example, indictor (146) is within the range of a size “14”implant.

It should be understood that auto-tensioning feature (166) may have aspring constant that is large enough to sufficiently drive plungerportion (130) proximally so that flexible tube (172) may suitably engageLES (6); yet weak enough such that once resilient flexible tube (172)sufficiently engages LES (6), the magnetic attraction between magnets(174, 176) keeping tube (172) closed does not break and LES (6) does notdeform. In other words, auto-tensioning feature (160) has a springconstant within the acceptable range such that flexible tube (172)properly engages LES (6) without deforming LES (6) or disengagingmagnets (174, 176). Auto-tensioning feature (166) may include a springconstant that provides a substantially consistent force against plungerportion (130) during the active length in which auto-tensioning feature(166) drives plunger portion (130). For instance, the output forceprovided by auto-tensioning feature (166) may deviate by around 5% fromwhen plunger portion (130) is in the most distal position as compared toplunger portion (130) in the most proximal position. Of course, anysuitable deviation in output force provided by auto-tensioning feature(166) may be used as would be apparent to one having ordinary skill inthe art in view of the teachings herein.

With the suitable measurement of the LES (6) attained, the operator mayremove instrument (100) from the patient through any suitable techniquethat would be apparent to one having ordinary skill in view of theteachings herein. For example, the operator may push plunger portion(130) back into the distal position, use conventional graspinginstrument (50) to grasp tube (172) into the opened position, dissociatetube (172) from LES (6), and then remove instrument (100) from patient.Alternatively, the operator may pull plunger portion (130) to theproximal-most position, thereby fully retracting flexible tube (172)into exterior sheath (162) to the point where a proximal edge of distaltip (178) abuts a distal edge of distal end (165). The operator mayutilize the measurement of the LES (6) to select an implant that is mostappropriate for the patient at hand, to modify an implant so that theimplant is at the most appropriate configuration for the patient athand, and/or for any other purposes.

III. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

An apparatus, the apparatus comprising: (a) a handle assembly, whereinthe handle assembly comprises: (i) a handle body, and (ii) a plungerportion slidably coupled with the handle body; (b) a shaft assemblyextending distally from the handle assembly, wherein the shaft assemblycomprises: (i) an external sheath fixed to the handle body, and (ii) aninterior shaft coupled to the plunger portion, wherein the interiorshaft is slidable relative to the external sheath; (c) an end effectorconfigured to encompass a bodily lumen, wherein the end effectorcomprises: (i) a flexible member comprising a distal tip, wherein theflexible member extends distally from the interior shaft, (ii) a firstcoupling element fixed to the distal tip of the flexible member, and(iii) a second coupling element fixed to the external sheath, whereinthe first and second coupling elements are configured to be magneticallyattracted to each other, wherein the first and second coupling elementsare biased toward each other such that the flexible member defines anadjustable loop; and (d) an auto-tensioning feature configured to biasthe plunger portion proximally relative to the handle body.

Example 2

The apparatus of Example 1, wherein the handle body comprises aplurality of indicator markings.

Example 3

The apparatus of Example 2, wherein the plunger portion comprises anindicating feature.

Example 4

The apparatus of any one or more of Examples 1 through 3, wherein theplunger portion defines a locking recess.

Example 5

The apparatus of Example 4, wherein the handle assembly furthercomprises a locking clip, wherein the locking clip is configured matewith the locking recess of the plunger portion when the plunger portionis in a distal position.

Example 6

The apparatus of any one or more of Examples 1 through 5, wherein thehandle body defines proximal sleeve, wherein the plunger portion isslidably coupled within the proximal sleeve.

Example 7

The apparatus of Example 6, wherein the proximal sleeve comprises afirst flat surface, wherein the plunger portion comprises a second flatsurface, wherein the first flat surface and the second flat surface areconfigured to mate with each other to rotationally lock the plungerportion relative to the handle assembly.

Example 8

The apparatus of any one or more of Examples 1 through 7, wherein theplunger portion comprises an external plunger body and a support collarfixed within the external plunger body, wherein the interior shaft isfixed to the support collar.

Example 9

The apparatus of any one or more of Examples 1 through 8, wherein theauto-tensioning feature comprises a spring.

Example 10

The apparatus of Example 9, wherein the spring is housed within theexternal sheath of the shaft assembly.

Example 11

The apparatus of Example 10, wherein the external sheath comprises aspacer tube, wherein the spring abuts against the spacer tube.

Example 12

The apparatus of Example 11, wherein the plunger portion defines adistal opening, wherein a portion of the spring extends into the distalopening.

Example 13

The apparatus of any one or more of Examples 1 through 12, wherein theflexible member comprises a resilient tube.

Example 14

The apparatus of Example 13, wherein the resilient tube is biased todefine the adjustable loop.

Example 15

The apparatus of any one or more of Examples 1 through 14, wherein thehandle assembly comprises a locking collar, wherein the external sheathis fixed to the locking collar.

Example 16

The apparatus of any one or more of Examples 1 through 15, wherein thefirst coupling element comprises a magnet.

Example 17

An apparatus, the apparatus comprising: (a) a handle assembly, whereinthe handle assembly comprises: (i) a handle body, and (ii) a plungerportion slidably coupled with the handle body; (b) a shaft assemblyextending distally from the handle assembly, wherein the shaft assemblycomprises: (i) an external sheath fixed to the handle body, and (ii) aninterior shaft coupled to the plunger portion, wherein the interiorshaft is slidable relative to the external sheath; (c) an end effectorconfigured to encompass a bodily lumen, wherein the end effectorcomprises a flexible member comprising a distal tip, wherein theflexible member extends distally from the interior shaft, wherein theflexible member is biased to define an adjustable loop; and (d) anauto-tensioning feature positioned within the external sheath and aroundthe interior shaft, wherein the auto-tensioning feature is configured tobias the plunger portion proximally relative to the handle body toreduce the adjustable loop defined by the flexible member.

Example 18

The apparatus of Example 17, wherein the plunger portion is rotationallyfixed relative to the handle body.

Example 19

The apparatus of any one or more of Examples 17 through 18, wherein theexternal sheath comprises a spacer tube, wherein the auto-tensioningfeature abuts against the spacer tube.

Example 20

An apparatus, the apparatus comprising: (a) a handle assembly, whereinthe handle assembly comprises: (i) a static body, and (ii) an actuatingbody slidably coupled with the static body; (b) a shaft assemblyextending distally from the handle assembly, wherein the shaft assemblycomprises: (i) an external sheath fixed to the static body, wherein theexternal sheath defines a distal opening, and (ii) an interior shaftfixed to the actuating body; (c) an end effector configured to encompassa bodily lumen, wherein the end effector comprises a flexible memberattached to the interior shaft, wherein a distal portion of the flexiblemember extends distally past the distal opening of the external sheath,wherein the distal portion of the flexible member is biased to form anadjustable loop; and (d) an auto-tensioning feature configured to biasthe actuating body portion proximally relative to the static body.

IV. Miscellaneous

It should also be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1-20. (canceled)
 21. An apparatus, comprising: (a) a base assembly,wherein the base assembly comprises: (i) a base body, and (ii) anactuating body longitudinally movable relative to the base body, whereinthe actuating body is biased proximally relative to the base body; (b) ashaft assembly extending distally from the base assembly, wherein theshaft assembly comprises: (i) a first elongate member coupled to thebase body, and (ii) a second elongate member coupled to the actuatingbody, wherein the second elongate member is longitudinally movablerelative to the first elongate member; and (c) a flexible memberextending distally from the second elongate member to a distal tip,wherein the distal tip is configured to be magnetically attracted to aportion of the first elongate member, wherein the distal tip is biasedtoward the portion of the first elongate member such that the flexiblemember defines an adjustable loop.
 22. The apparatus of claim 21,wherein the base body comprises a plurality of indicator markings. 23.The apparatus of claim 22, wherein the actuating body comprises anindicating feature.
 24. The apparatus of claim 21, wherein the actuatingbody defines a locking recess.
 25. The apparatus of claim 24, whereinthe base assembly further comprises a locking clip, wherein the lockingclip is configured to mate with the locking recess of the actuating bodywhen the actuating body is in a distal position.
 26. The apparatus ofclaim 21, wherein the base body defines a proximal sleeve, wherein theactuating body is slidably coupled within the proximal sleeve.
 27. Theapparatus of claim 26, wherein the proximal sleeve comprises a firstflat surface, wherein the actuating body comprises a second flatsurface, wherein the first flat surface and the second flat surface areconfigured to mate with each other to rotationally lock the actuatingbody relative to the base body.
 28. The apparatus of claim 21, whereinthe actuating body comprises an external plunger body and a supportcollar fixed within the external plunger body.
 29. The apparatus ofclaim 21, wherein the actuating body is biased proximally relative tothe base body by a spring.
 30. The apparatus of claim 29, wherein thespring is housed within the first elongate member of the shaft assembly.31. The apparatus of claim 30, wherein the first elongate membercomprises a spacer tube, wherein the spring abuts against the spacertube.
 32. The apparatus of claim 31, wherein the actuating body definesa distal opening, wherein a portion of the spring extends into thedistal opening.
 33. The apparatus of claim 21, wherein the flexiblemember comprises a resilient tube.
 34. The apparatus of claim 33,wherein the resilient tube is biased to define the adjustable loop. 35.The apparatus of claim 21, wherein the base assembly comprises a lockingcollar, wherein the first elongate member is fixed to the lockingcollar.
 36. The apparatus of claim 21, wherein the distal tip comprisesa magnet.
 37. An apparatus, comprising: (a) a shaft assembly, whereinthe shaft assembly comprises: (i) a first elongate member, and (ii) asecond elongate member, wherein the second elongate member islongitudinally movable relative to the first elongate member; (b) aflexible member extending distally from the second elongate member to adistal tip, wherein the flexible member is biased to define anadjustable loop; and (c) an auto-tensioning feature positioned withinone of the first or second elongate members and around the other of thefirst or second elongate members, wherein the auto-tensioning feature isconfigured to bias the second elongate member proximally relative to thefirst elongate member to reduce the adjustable loop defined by theflexible member.
 38. The apparatus of claim 37, wherein the secondelongate member is rotationally fixed relative to the first elongatemember.
 39. The apparatus of claim 37, wherein the first elongate membercomprises a spacer tube, wherein the auto-tensioning feature abutsagainst the spacer tube.
 40. An apparatus, comprising: (a) a shaftassembly, wherein the shaft assembly comprises: (i) a first elongatemember, and (ii) a second elongate member, wherein the second elongatemember is longitudinally movable relative to the first elongate member,wherein the second elongate member is biased proximally relative to thefirst elongate member; and (b) a flexible member extending distally fromthe second elongate member to a distal tip, wherein the distal tip isconfigured to be magnetically attracted to a portion of the firstelongate member, wherein the distal tip is biased toward the portion ofthe first elongate member such that the flexible member defines anadjustable loop.